FDA 510(k) clearances — page 816
clearances on record, most recent first.
Clearances — page 816
81,501–81,600 of 176,637- K003872 — GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K003883 — MOLINA ORBITAL MALAR DISTRACTOR
- K010060 — RITA STARBURST XLI ELECTROSURGICAL DEVICE
- K002011 — GLUTARTEST 1 REAGENT STRIP
- K002621 — GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
- K002624 — GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
- K002930 — INSTACCULT
- K003042 — V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT
- K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
- K003341 — EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
- K003342 — WAKO CRP-UL, CRP-UL CALIBRATOR SET
- K003459 — PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
- K003579 — NARKOMED MRI-2, MODEL NM-MRI-2
- K003688 — VIEW READING STATION
- K003708 — ADVANTAGE THC/COCAINE TEST
- K003959 — QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
- K010002 — CONTOUR POLARIS URETERAL STENT
- K000852 — RENEW NEUROSTIMULATION SYSTEM
- K000884 — BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
- K002061 — A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
- K003316 — OTI CERAMIC FEMORAL HEAD SYSTEM
- K003358 — QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
- K003368 — ACROTHERM
- K003422 — EDTA ROOT CANAL CLEANSER
- K003481 — CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
- K003484 — NETRA WORKSTATION AND NETRAMD SOFTWARE
- K003554 — HARDYDISK TRIMETHOPRIM 5MCG
- K003964 — TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B
- K010073 — SPLINE DENTAL IMPLANT SYSTEM
- K001097 — ACTIVE ARRAY CATHETER, MODEL CS-2000
- K001528 — PC FLOW +
- K003286 — SYMPHONY GRAFT DELIVERY SYSTEM
- K003297 — MAMMOTOME HAND HELD PROBE, MODEL MHH8
- K003453 — SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS
- K003454 — A1-CS-SB Y-ADAPTER, MODEL 124 871
- K003479 — U-SYSTEMS ULTRASOUND SYSTEM USI-2000
- K003492 — ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS
- K003736 — MRI LINE MARKER
- K003931 — VIVID 7 WITH SONOPAC, MODEL FB0008XX
- K003938 — TRAK BACK II
- K001283 — LIFEMATE HEMOFILTRATION SYSTEM
- K002331 — PROFILE-ER
- K002638 — FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
- K003174 — ELECSYS DHEA-S
- K003278 — COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
- K003284 — PHLEBOPUMP, MODEL 1000
- K003393 — MAXILLARY DISTRACTOR
- K003508 — NC-STAT
- K003556 — HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
- K003575 — MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
- K003583 — LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
- K003751 — HYALURONIDASE REAGENT, MODEL CAT#2212
- K003895 — X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21
- K003901 — ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
- K003928 — TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
- K003745 — LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
- K003771 — ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K003817 — PATTERN RESIN
- K003991 — CD-CAL PLUS CALIBRATOR
- K001259 — 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM
- K001775 — ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
- K002450 — GENUA MENOPAUSE MONITOR TEST KIT
- K002457 — !NSURE FECAL OCCULT BLOOD TEST
- K003223 — GEON DIGITAL CLINICAL THERMOMETER
- K003226 — THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
- K003231 — HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
- K003253 — BIOMET'S MINIMALLY CONSTRAINED ELBOW
- K003258 — MS-ONE, MODEL MS-1
- K003348 — E.N.S.I. RETRACTABLE SAFETY SYRINGE
- K003406 — GUARDED NEEDLE 2000
- K003476 — MPS ACACIA PAIN KIT
- K003536 — HARDYDISK NAFCILLIN, 1 MCG
- K003537 — HARDYDISK RIFAMPIN, 5MCG
- K003686 — HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
- K003775 — PORTABLE BREAST COMPRESSION DEVICE
- K003783 — MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER
- K003862 — MADA WHEELCHAIRS
- K003874 — CBC-4K HEMATOLOGY CONTROL
- K003967 — CA 125 II CALCHECK
- K003969 — ELECSYS CA 125 II CALSET
- K003970 — CONTOUR LABRAL NAIL, MODEL 533520A
- K010011 — TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM
- K010027 — MAXIM KNEE SYSTEM
- K001174 — COSMED QUARK
- K001577 — OUTBACK CATHETER
- K001859 — PENILE CONSTRICTOR RING
- K002056 — MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
- K002067 — RADIANALYZER, MODEL 12710
- K002163 — MICROSTREAM EXTERNAL BATTERY CHARGER
- K002381 — PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES
- K003273 — LACTOSORB SCREW ANCHOR
- K003313 — FILAC FAS TEMP ELECTRONIC THERMOMETER
- K003396 — BURN JEL PLUS
- K003485 — CARE PROVIDER STATION ADDITION OF WEIGHT SCALE
- K003513 — TAXOL ADMINISTRATION SET
- K003683 — AVANTE CURELIGHT
- K003848 — HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
- K003902 — MULTITRACK ANGIOGRAPHIC CATHETER
- K003972 — NUMED GHOST II PTA CATHETERS
- K003199 — TRIAD II MODULAR TOTAL HIP SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.